Analysis of the short-term efficacy of ustekinumab for intractable Crohn′s disease: a multicenter retrospective observational study
10.3760/cma.j.cn101480-20210326-00025
- VernacularTitle:乌司奴单克隆抗体治疗难治性克罗恩病的短期疗效分析：一项多中心回顾性观察性研究
- Author:
Jiayin YAO
1
;
Xiaomei SONG
;
Qiao YU
;
Yan CHEN
;
Hong GUO
;
Min ZHI
;
Min ZHANG
Author Information
1. 中山大学附属第六医院消化内科，广州 510655
- Publication Type:Journal Article
- Keywords:
Crohn′s disease;
Ustekinumab;
Efficacy, short-term;
Multicenter;
Remission;
Response
- From:
Chinese Journal of Inflammatory Bowel Diseases
2021;05(2):151-155
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the short-term efficacy of ustekinumab (UST) in the treatment of intractable Crohn′s disease (CD) .Methods:Clinical data of intractable CD patients with the administration of UST in the Sixth Affiliated Hospital of Sun Yat-sen University, the Second Affiliated Hospital of Zhejiang University School of Medicine and Xinqiao Hospital of Army Medical University from March 1st to September 30th, 2020 were analyzed retrospectively. All of the patients started UST at the recommended dose at 0, 8th, 16th/20th weeks. The clinical response and remission were evaluated by Crohn′s disease activity index (CDAI) . The endoscopic response and remission were evaluated by simple endoscopic score for Crohn′s disease (SES-CD) . The life quality was evaluated by inflammatory bowel disease questionnaire (IBDQ) . The clinical and endoscopic responses and IBDQ scores were analyzed statistically at 8th week and (or) at 16th/20th week. The differences in body mass index (BMI) , albumin, hemoglobin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) among 0, 8th, 16th/20th weeks after UST treatment were compared and analyzed.Results:A total of 18 CD patients were enrolled, including 12 males and 6 females. The age was 30.5 (26.0, 38.0) years old while the disease duration was 6.5 (1.9, 10.0) years. According to Montreal classification, 15 (83.3%) patients were diagnosed at the age from 17 to 40 years old, the disease involved the ileocolon in 13 (72.2%) patients and the non-stricturing non-penetrating type was in 14 (77.8%) patients. Ten (55.6%) patients were complicated with perianal disease and 6 (33.3%) patients had undergone surgeries. Eleven (61.1%) patients had received treatment of glucocorticoids, 13 (72.2%) patients had received immunosuppressants, and 16 (88.9%) patients had received biologics. The clinical remission was observed in 72.2% (13/18) patients while 77.8% (14/18) had clinical response at 8th week after first use of UST. The clinical remission was observed in 88.9% (16/18) patients while 94.4% (17/18) had clinical response at 16th/20th week. Endoscopic remission rate was 28.6% (4/14) while endoscopic response rate was 78.6% (11/14) at 16th/20th week. The level of BMI [ (21.0 ± 0.5) kg/m 2 and (21.7 ± 0.4) kg/m 2 vs. (19.9 ± 0.6) kg/m 2, all P<0.05], albumin[ (41.7 ± 3.7) g/L and (41.7 ± 3.7) g/L vs. (39.6 ± 4.6) g/L, all P<0.05], and hemoglobin[ (134.9 ± 12.0) g/L and (135.9 ± 12.3) g/L vs. (126.7 ± 15.8) g/L, all P<0.05] at 8th week and at 16th/20th week were increased significantly than those at 0 week. And the CRP at 8th week and at 16th/20th week were significantly lower than that at 0 week [10.2 (5.1, 17.5) mg/L and 7.6 (3.2, 14.7) mg/L vs. 15.5 (12.3, 31.4) mg/L, all P< 0.05]. However, compared with the baseline value at 0 week, there were no significant difference in ESR and IBDQ score at 8th, 16th/20th weeks (all P>0.05) . Conclusion:UST can effectively improve clinical symptoms and ameliorate endoscopic manifestations of intractable CD patients in the short term.
